The present invention generally relates to fluid specimen collection devices, and more specifically relates to a saliva sampling device and method for extracting saliva for use in diagnostic tests.
Unlike other forms of fluid specimens such as blood or urine, collection of oral fluid, such as saliva, for diagnostic purposes is complicated by many factors, for example, the low volumes of salivary fluid secreted, the relatively high viscosity of the fluid, and the diverse anatomic dispersion of the salivary glands. These problems become compounded when a single saliva sample is to be divided into two or more portions as is sometimes desired. Most techniques for collection involve the use of capillary tubes, suction into micro pipettes, chewing on paraffin, and/or aspiration from the mouth into polypropylene syringes.
In addition, testing of salivary specimens has not yet been extensively developed. Blood and urine samples have for long been the primary fluids used for testing for disease as well as for evidence of substance abuse. However, it is now known that human saliva carries lymphocytes, plasma cells and immunoglobulins that are directly related to the immunoglobulins found in the blood. In addition, saliva carries immunoglobins that are believed to be peculiar to saliva, for example, the antibody known as secretory IgA. Because of the association between immunoglobulins of the blood and saliva, as well as the occurrence of secretory IgA, antigen-antibody tests have been conducted on salivary fluid to assess the value of such tests as screening tools for disease.
U.S. Pat. No. 5,922,614 to Cesarczyk describes a Sample Collection Method with Extraction Sleeve. The device is designed for collecting saliva or urine samples using an absorbent, elongate foam member secured within a hollow tube and having a portion extending therefrom. The foam member is used to absorb a fluid specimen. The foam member and hollow tube are slidably mounted within an outer sleeve covering the foam member. Fluid is collected by a user exerting pressure against the sleeve to compress the foam member and thereby release the fluid. According to Cesarczyk, the device provides an aseptic, easy to use device for collecting a fluid sample such as saliva.
The present invention exemplifies an improved oral fluid collection device which is easier to use than other devices in the field that are those presently available.
The present invention provides an improved sampling device for collecting and delivering an oral fluid specimen such as saliva, for diagnostic testing.
Accordingly, a method and device are provided for both collecting and delivering a fluid sample, such as blood, urine or saliva for diagnostic testing. It is noted that the device is especially advantageous for samples of which only a low volume of sample is available for collection, specifically saliva.
The device generally comprises an expresser, having a distal open end connected to a port, and a generally closed proximal end. The expresser is adapted to receive an absorbent member substantially saturated with a fluid specimen, through the distal opening. As the absorbent member is pulled through the distal opening and into the port, the port provides means for compressing the absorbent member to effect expression of the fluid specimen therefrom the absorbent member.
Connected to the expresser distal open end is a platform for collecting at least a portion of the specimen as it is expressed from the absorbent member. The platform preferably is adapted to provide means for testing the fluid specimen. For example, the platform may include a sample well for receiving drops of expressed fluid. To facilitate flow of the expressed fluid into the sample well, the expresser may be disposed at an angle with respect to the generally horizontal platform.
The sample well may include a first port and a second port, comprising, for example a test port and a confirmation port respectively. In addition, the platform may include a lateral flow test strip in fluid communication with the test port, and a confirmation container in fluid communication with the confirmation port. Preferably, the platform has a closed top surface encasing the test strip, and a viewing window exposing a portion of the strip.
In one especially advantageous embodiment, the device further comprises means for dividing the fluid expressed from the expresser. For example, a partition, disposed between the test and confirmation ports and extending at least partially into the expresser container is provided. A ratio of confirmation sample to lateral flow sample could be adjusted by changing location and/or configuration of the dividing partition.
In one embodiment of the invention, an absorbent member is provided, as well as tether means for enabling manual handling of the absorbent member. The expresser distal opening may include an inlet, sized for passage of the absorbent member, and a longitudinal slot in communication with the inlet, sized for passage of the tether means. By controlling the pulling of the tether, the user may cleanly and controllably express the fluid, drop by drop, to be used for testing/diagnostic purposes.